Kwak Soo Heon, Han Kyung Ah, Kim Eun Sook, Choi Sung Hee, Won Jong Chul, Yu Jae Myung, Oh Seungjoon, Yoo Hye Jin, Kim Chong Hwa, Kim Kyung-Soo, Chun SungWan, Kim Yong Hyun, Cho Seung Ah, Kim Da Hye, Park Kyong Soo
Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University, Seoul, South Korea.
Diabetes Obes Metab. 2024 Oct;26(10):4203-4212. doi: 10.1111/dom.15738. Epub 2024 Jul 26.
To evaluate the long-term safety and efficacy of enavogliflozin monotherapy (0.3 mg/day) in individuals with type 2 diabetes mellitus (T2DM).
Following a 24-week randomized, double-blind treatment period with enavogliflozin 0.3 mg/day (n = 77) or placebo (n = 69), consenting participants received enavogliflozin 0.3 mg/day for an additional 28 weeks during an open-label extension (OLE) period. The safety and efficacy of enavogliflozin were assessed at Week 52.
A total of 37 participants continued enavogliflozin (maintenance group), and 26 participants switched from placebo to enavogliflozin (switch group). No additional adverse drug reactions related to enavogliflozin were observed during the OLE period. At Week 52, glycated haemoglobin (HbA1c) and fasting plasma glucose were significantly lower than at the baseline, by 0.9% and 24.9 mg/dL, respectively, in the maintenance group (p < 0.0001 for both), and by 0.7% and 18.0 mg/dL, respectively, in the switch group (p < 0.0001 and p = 0.002). The proportions of participants reaching HbA1c 7.0% (53 mmol/mol) at Week 52 were 69.4% in the maintenance group and 65.4% in the switch group. A significant increase in urine glucose-to-creatinine ratio was observed at Week 52, by 84.9 g/g and 67.1 g/g in the maintenance and switch groups, respectively (p < 0.0001 for both). Body weight in both groups decreased significantly (p < 0.0001) from baseline to Week 52, by 3.5 kg and 3.8 kg in the maintenance and switch groups, respectively.
Enavogliflozin 0.3 mg monotherapy provides long-term glycaemic control in T2DM and is safe and well tolerated during a 52-week treatment period.
评估恩格列净单药治疗（0.3毫克/天）对2型糖尿病（T2DM）患者的长期安全性和疗效。
在24周的随机双盲治疗期内，患者接受0.3毫克/天的恩格列净治疗（n = 77）或安慰剂治疗（n = 69），之后在开放标签延长期（OLE）中，同意继续参与的患者再接受28周的0.3毫克/天恩格列净治疗。在第52周时评估恩格列净的安全性和疗效。
共有37名参与者继续使用恩格列净（维持组），26名参与者从安慰剂组转至恩格列净组（转换组）。在OLE期间未观察到与恩格列净相关的额外药物不良反应。在第52周时，维持组糖化血红蛋白（HbA1c）和空腹血糖显著低于基线水平，分别降低了0.9%和24.9毫克/分升（两者p < 0.0001）；转换组分别降低了0.7%和18.0毫克/分升（p < 0.0001和p = 0.002）。在第52周时，维持组和转换组达到糖化血红蛋白7.0%（53毫摩尔/摩尔）的参与者比例分别为69.4%和65.4%。在第52周时，维持组和转换组的尿糖与肌酐比值均显著增加，分别增加了84.9克/克和67.1克/克（两者p < 0.0001）。两组体重从基线到第52周均显著下降（p < 0.0001），维持组和转换组分别下降了3.5千克和3.8千克。
0.3毫克恩格列净单药治疗可为T2DM患者提供长期血糖控制，且在52周治疗期内安全且耐受性良好。
